510(k) · Cleared
ClearedCirqlator Intrathoracic Pressure Regulator (Itpr)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Circulatory Systems, Inc. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Jun 20, 2007 as substantially equivalent to K022906 (Cprx, LLC, 2003) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Jun 20, 2007
- Review
- 120 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022906 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022906 Resqpod Circulatory EnhancerCprx, LLC · 2003
- 1 generation backK033401 Modification to Resqpod Circulatory EnhancerAdvanced Circulatory Systems, Inc. · 2003
- This deviceK070490 Cirqlator Intrathoracic Pressure Regulator (Itpr)Advanced Circulatory Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK172388 Vpod ItprAdvanced Circulatory System, A Wholly Owned Subsidiary OF · 2017
Most influential descendants
Showing 1 of 1 · See all- K172388Vpod ItprAdvanced Circulatory System, A Wholly Owned Subsidiary OF · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022906 | Resqpod Circulatory Enhancer | Cprx, LLC | 2003 | — |
| −1 | K033401 | Modification to Resqpod Circulatory Enhancer | Advanced Circulatory Systems, Inc. | 2003 | — |
| 0 (this device) | K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr) | Advanced Circulatory Systems, Inc. | 2007 | — |
| +1 | K172388 | Vpod Itpr | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BWF device
- #1 K241152 InSeescore 9.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022906 | Resqpod Circulatory EnhancerSummary page 1…apeutic (incentive) Device: Intrathoracic Pressure Regulator (ITPR) Predicate Devices: ResQPOD® Circulatory Enhancer - K022906, K033401 Bird Mark 8 ventilator - pre-amendment IDevice Description: The CirQlator' m is… | 2003 |
| * | K033401 | Modification to Resqpod Circulatory EnhancerSummary page 1…incentive) Device: Intrathoracic Pressure Regulator (ITPR) Predicate Devices: ResQPOD® Circulatory Enhancer - K022906, K033401 Bird Mark 8 ventilator - pre-amendment IDevice Description: The CirQlator' m is an intrat… | 2003 |
| * | — | Bird Mark 8 ventilator Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172388 | Vpod Itpr | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172388 (Advanced Circulatory System, A Wholly Owned Subsidiary OF, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K022906.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CirQlator M Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070490: Cirqlator Intrathoracic Pressure Regulator (Itpr).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070490
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026